European Medicines Agency (EMA) updated the page Clinical Trials Information System (CTIS): online modular training program on March 16, 2022, by updating the below document in Module 19- CTIS for Small and Medium Sized Enterprises (SMEs) and academia:
- Quick guide – Introduction: CTIS for SMEs and Academia – Module 19 (v1.2): It includes added information for data protection and confidentiality in CTIS during the life-cycle of a clinical trial. It informs about the functionalities to upload documents that are not subjected to publication alongside a functionality to upload documents for publication and to defer publication to protect Commercially Confidential Information (CCI). Users can upload two versions of the same documents. The above functionality is available to documents in the CTD dossier. It also updates the section for roles and permission by updating information in a tabular manner.